Senior/Principal Research Associate, Analytical DevelopmentPosition SummaryWe are seeking a Senior/Principal Research Associate to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at CRISPR Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. The individual will develop quantitative cell-based assays measuring gene editing and biological functions in target and non-target cells. The successful candidate will independently design, perform, and analyze experiments for multiple preclinical and clinical programs, and will work independently to support process development, product characterization, and technical transfer to CMOs and GMP test labs.

Responsibilities

  • Develop and qualify flow cytometry and other cell-based methods to measure gene editing, gene expression, and function. Examples include measurements of T cell subsets, exhaustion markers, and CAR expression in immuno-oncology products.
  • Act as point person to conduct key analytical testing to characterize cellular drug products.
  • Collaborate with Process Development to generate and analyze process development data to develop an understanding of cellular product critical quality attributes to guide testing and process control strategies.
  • Develop data sets supporting product specification and for qualification and/or validation of cell-based assays at CMOs and GMP test labs.
  • Maintain clear and complete experimental records. Present findings in meetings.
  • Document development activities in Technical Reports supporting regulatory filings.
  • Support drafting and revising protocols, SOPs and regulatory sections for filings.

Minimum Qualifications

  • BS in life sciences with 5+ years of relevant assay development experience in industry or an MS with 3+ years of relevant experience.
  • Flow cytometry experience is a must. Ability to design and execute multi-color flow cytometry experiments. Ability to analyze complex data sets and troubleshoot.
  • Experience with cell-based assay development for immunology or immuno-oncology products.
  • Experience with a range of cell and molecular biology techniques.
  • Ability to work independently as well as part of a fast-paced, results-oriented team.
  • Excellent oral and written communication skills.
  • Highly organized with significant attention to detail.
  • Track record of intellectually challenging oneself to enhance scientific abilities.

Preferred Qualifications

  • Experience in assay development for cell and gene therapy products.
  • Experience in analytical method qualification and validation.
  • Knowledge of relevant guidance on analytical development and validation (USP, ICH, FDA, EMA).
  • Experience working with contract manufacturing organizations and in tech transfer to QC labs.

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